Pre-Screening of Participants with Type 2 Diabetes and Foot Ulcers for Enrollment into a Bacteriophage Therapy Pilot Study.

Abstract

ObjectiveTo evaluate the clinical severity and microbiological characteristics of participants with type 2 diabetes and foot ulcers (DFUs) screened for eligibility into a bacteriophage therapy pilot study.Research Design And MethodsAdults aged (≥18 years) with type 2 diabetes mellitus (T2DM) and active DFUs presenting to a tertiary care centre were screened using predefined eligibility criteria. Ulcers were graded according to the University of Texas Diabetic Foot Classification System. Microbiological analysis included standard culture techniques and biochemical tests for identification of microorganism. Descriptive statistics were used to summarize ulcer severity, microbial patterns, and eligibility outcomes.ResultsA total of 595 individuals were screened. Grade 3 ulcers accounted for 51.1% of cases, followed by Grade 2 (29.1%) and Grade 1 (19.8%). Monomicrobial infections were identified in 63.7% of individuals, polymicrobial infections in 17.6%, and no growth in 18.7%. Gram-negative organisms predominated, including Pseudomonas spp. (n = 74), Escherichia spp. (n = 60), Klebsiella spp. (n = 50), Proteus spp. (n = 43), and Acinetobacter spp. (n = 25). Among Gram-positive organisms, Staphylococcus spp. (n = 81) and Enterococcus spp. (n = 43) were common.ConclusionsThe screened population demonstrated a high burden of advanced Grade 3B DFUs, predominantly associated with Gram-negative pathogens amenable to bacteriophage targeting. But this pilot study intentionally focused on Grade 1B and Grade 2B ulcers to assess the feasibility and safety of bacteriophage therapy in predefined, less severe DFUs. This pre-screening process supported the feasibility and enrollment of eligible participants for the subsequent bacteriophage therapy pilot study.